Katalyst Healthcares and Life Sciences
Responsibilities:
- Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.
- Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment.
- Develop test plans, inspect, and assess material's compliance based on dimensional and attribute acceptance criteria, while documenting and communicating inspection results.
- Determine optimal measurement devices to perform inspections. Understand AQL tables and how to select the correct sampling rate based on quality criteria.
- Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
- Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
- Lead the development and implementation of visual and physical inspections of injection molded mechanical, electrical, and packaging components to ensure they meet specifications.
- Assist Quality Engineers and manufacturing personnel with calibration activities, which includes reviewing and retrieving calibrated equipment necessary for processing.
- Managing Root Cause Analysis activities stemming from MRB, RMA, and CAPA.
- Analysing/trending non-conformances through NCMRs and RMAs.
- Assist in supplier audits and visits, as required.
- Assist in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).
- Support other duties as assigned by manager.
- Bachelor's degree required in Engineering, Biomedical Engineering, or Life Sciences.
- Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices is required.
- Experience with new product development required.
- Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required.
- Experience in metrology required.
- Strong organizational skills, detail oriented, and the ability to meet changing deadlines on a fast-moving environment.
- Strong documentation capability for protocol and report generation and review.
- Ability to communicate effectively within a technical environment.
- Team player who celebrates winning together.
- No travel required.
- Must have Experience with New Product Development.
- Must have All required knowledge/skill on description. Here are some other experiences that are plus.
- Must have Design Quality Engineering.
- Must have Validation Protocols.
- Must have FMEA Risk analysis.
- Must have Supplier qualifications.
- Must have Mechanical, Electric experience.